Assessment of Laboratory Tests When Proficiency Testing is Not Available (GP29-A2)
HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays (I/LA29-P)
Quality Control for Commercial Microbial Identification Systems (M50-P)

CLSI submits the following for vote as a candidate-for-advancement consensus documents.  The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums.  

GP29-A2— Assessment of Laboratory Tests When Proficiency Testing is Not Available; Approved Guideline—Second Edition
This document offers methods to assess test performance when proficiency testing (PT) is not available; these methods include examples with statistical analyses. This document is intended for use by laboratory managers and testing personnel in traditional clinical laboratories as well as in point-of-care and bedside testing environments. The deadline for the completed ballot for GP29-A2 to be received at the CLSI offices is 10 March 2008.

M50-P—Quality Control for Commercial Microbial Identification Systems; Proposed Guideline
This document provides guidance for quality control of commercial systems for microbial identification from culture, including information that pertains to manufacturers, distributors, and laboratory users. The intent is to ensure optimal performance of a microbial identification system in an efficient (streamlined) manner. The deadline for the completed ballot for M50-P to be received at the CLSI offices is 10 March 2008.

Second Notice

I/LA29-P—Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Proposed Guideline
This guideline will describe criteria for optimizing methods that utilize flow cytometry and other conventional and multiplex platforms. The deadline for the completed ballot for I/LA29-P to be received at the CLSI offices is 15 February 2008.

Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the CLSI offices by the above deadline.

In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.

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